MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45040
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject flow diverter was resheathed approximately seven times and the patient's internal carotid terminus vessel had vasospasm.The vessel vasospasm constricted the subject flow diverter and prevented it from opening which was realized after contrast injection.The physician administered verapamil and cardapine to treat the vasospasm which resolved.Then removed the device and replaced it with a second flow diverter which had a proximal twist/kink that was unable to be resolved with deployment.The second device was resheathed and removed form the patient anatomy.A third device was used and procedure was completed successfully.Patient was reported to be doing well.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The reported lot number was confirmed from the returned packaging.On visual/microscopic inspection, only the stent was returned.The stent was not fully opened at the proximal end.Frayed edges were noted at the proximal and distal ends.Procedural fluids were present on the stent.A functional test could not be performed as only the stent was returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that there were no anomalies noted to the stent delivery system prior to use, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure and the patient¿s anatomy was type 3 tortuous.According to the physician, there was no adverse event related to the first surpass stent system.The patient had a vasospasm which constricted the stent from opening.They removed the stent and administered verapamil and cardapine to treat the vasospasm.There was a surgical delay of 20 mins but the patient did not suffer any adverse consequences as a result of the procedure or delay or device malfunction or due to the reported event and the patient¿s current condition is doing well.The device was returned and the stent was not fully opened at the proximal end and frayed edges were noted.According to additional information this occurred when the patient had a vasospasm in the internal carotid artery terminus which caused the damage to the stent.An assignable cause of anticipated procedural complication will be assigned to the reported patient vasospasm serious as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.An assignable cause of procedural factors will be assigned to the reported stent failed/unable to open and to the analyzed stent deformed as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the subject flow diverter was resheathed approximately seven times and the patient's internal carotid terminus vessel had vasospasm.The vessel vasospasm constricted the subject flow diverter and prevented it from opening which was realized after contrast injection.The physician administered verapamil and cardapine to treat the vasospasm which resolved.Then removed the device and replaced it with a second flow diverter which had a proximal twist/kink that was unable to be resolved with deployment.The second device was resheathed and removed form the patient anatomy.A third device was used and procedure was completed successfully.Patient was reported to be doing well.

• Brand Name: SURPASS EVOLVE 4.5MM X 40MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10627894
• Report Number: 3008881809-2020-00283
• Device Sequence Number: 2605058
• Product Code: OUT
• UDI-Device Identifier: 07613327375282
• UDI-Public: 07613327375282
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: FDS45040
• Device Catalogue Number: FDS45040
• Device Lot Number: 22241194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention